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Fred D. Lublin, MD Saunders Family Professor of Neurology

Thrice-Weekly Glatiramer Acetate for Relapsing Forms of Multiple Sclerosis: Findings from the GALA Study. Krzysztof Selmaj, MD, PhD Professor of Neurology Chair, Department of Neurology Medical University of Lodz Lodz, Poland. Fred D. Lublin, MD Saunders Family Professor of Neurology

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Fred D. Lublin, MD Saunders Family Professor of Neurology

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  1. Thrice-Weekly Glatiramer Acetate for Relapsing Forms of Multiple Sclerosis: Findings from the GALA Study • Krzysztof Selmaj, MD, PhD • Professor of Neurology • Chair, Department of Neurology • Medical University of Lodz • Lodz, Poland Fred D. Lublin, MD Saunders Family Professor of Neurology Director, The Corinne Goldsmith Dickinson Center for Multiple Sclerosis The Icahn School of Medicine New York, NY

  2. GALA: Study Design • Randomized, double-blind, placebo-controlled, parallel-group, phase III trial • Two study arms • Glatiramer acetate 40 mg TIW (n = 943) • Placebo (n = 461) • Primary endpoint • Annualized relapse rate at 1 year • Secondary endpoints • Cumulative number of new/newly enlarging T2 lesions at months 6 and 12 • Cumulative number of Gd-enhancing lesions on T1-weighted imaging at months 6 and 12 • Percentage brain volume change from baseline to month 12 Khan O, et al. Ann Neurol. 2013;73:705-713.

  3. GALA: Primary Efficacy of Glatiramer Acetate TIW 34% Relative Reduction in Relapse Rate Placebo Glatiramer acetate 40 mg TIW P <.0001 Annualized Relapse Rate Khan O, et al. Ann Neurol. 2013;73:705-713.

  4. GALA: Secondary EndpointsGlatiramer Acetate TIW vs Placebo 34.7% • Relative reduction in new/newly enlarging T2 lesions at months 6 and 12 44.8% • Relative reduction in Gd-enhancing lesions on T1-weighted imaging at months 6 and 12 9.4%  • Relative percentage brain volume change from baseline to month 12 Khan O, et al. Ann Neurol. 2013;73:705-713.

  5. Clinical Use of Glatiramer Acetate 40 mg TIW • In general, fewer injections is more convenient for and acceptable to patients • Thrice-weekly dosing may improve adherence in patients having difficulty with daily injections • Safety profile of thrice-weekly dosing is similar to that observed with once-daily dosing • GALA study not long enough to evaluate dose-effect on subcutaneous atrophy • Glatiramer acetate 40 mg TIW is approved for patients with relapsing forms of MS

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